Acute Intense Paraphilic Desire (DSM-V) Down-Regulation Via taVNS Neuro-Modulation [Transcutaneous Afferent Vagus Nerve] With Future Operative Implant Consideration

Paraphilia Clinical Trial

Official title:

Acute Paraphilic Pathway Down-Regulation In A Specialized Sensitive Group Using taVNS Modulation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05482412
• Other study ID #: PHD1002
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: December 15, 2024

Study information

• Verified date: July 2023
• Source: American University Of Montserrat
• Contact: Michel R Rice, MD [AUM]
• Phone: 14165588601
• Email: drrice[@]bettercalldoc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transcutaneous Afferent Vagus Nerve Stimulation [taVNS] is used to modulate persistent & intense desire control amongst a specific participant group. Testing Center Order of Deliver Number

Description:

taVNS Diagnostic Spectrum Testing Center Order of Delivery 1. - Addiction - Opioid 2. - Chronic Pain - Central 3. - Anxiety + Panic Disorder 4. - MDD - Major Depression Disorder 5. - Addiction - Nicotine 6. - ADHD 7. - Addiction - Stimulant 8. - Addiction - Sexual + Love 9. - Addiction - Paraphilia 10. - Parkinsons 11. - Immune Enhancing 12. - Addiction - Overeating RE-ORDERED CLINICAL TRIAL - NINE Physiologic effects of taVNS stimulation have been extensively researched for over 150 years. Drug-resistant depression (MDD), migraine headaches, pelvic pain modulation, facilitation of motor learning in neonates, post stroke rehabilitation and seizures are some of the conditions investigated with favorable results using taVNS intervention. taVNS physiologic & mental effects have been noted to have advantageous therapeutic results on a vast diagnostic spectrum. A clinical testing program for pre- and post-test was devised as a means to identify & measure treatment effects in specific T3, 4 and early 5 (Tanner) sub-group visual stimulation. The programmatic (software) of the stimulation medium created for this study is aimed to abate the use of a phallometric device purposed to measure sexual stimulation effects on participants. Great effort has been assigned for the preservation of visual data to be shared in the investigators' research centre with other researchers internationally. The participant testing platform created for this study allows for a full-proof research ethics anonymous & confidential registry & testing process (triple blind). Aggressive optimum (supra-threshold and below-pain threshold) taVNS is the therapeutic modality of choice in order to examine desire down-regulation effects using taVNS. DSM-V stock participants must be sub-grouped in the paraphilic categorical structure of the DSM-V.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• 21 to 60 years old - heterosexual identifying as he/him

Exclusion Criteria:

• 35 to 40 age group - heterosexual identifying as he/him

Related Conditions & MeSH terms

• Paraphilia

Intervention

Device:
• transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve
Direct superficial auricular sensory branch of Cr X [Cranial Nerve Ten Vagus]

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
American University Of Montserrat	Greg Thomas William Consultant Research, Queens University, Irene Becker Consultant, Coaching Certification for Pain Management, Kofi McNair Nyamekye B Eng. Op. Neuromod. Masters + 4th Yr Meds Student, Peter Martin BSc Forensic Psych, Masters in Education, JPH Internal Meds + Family Meds Rotation Teaching Assistant, Susan Jones MD PhD

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-Reported Questionnaire	Questions specific to participants' overall levels of desire intensity and distress in Likert Scale (1 no desire and 5 intense desire)	Day 1 Measured immediately post VITM testing of self-reported desire levels but before taVNS treatment
Other	Self-Reported Questionnaire	Questions specific to participants' overall levels of desire intensity and distress in Likert Scale (1 no desire and 5 intense desire)	Day 1 Measured immediately post VITM but post taVNS treatment
Other	Self-Reported Questionnaire	Questions specific to participants' overall levels of desire intensity and distress in Likert Scale (1 no desire and 5 intense desire)	Day 10 - After 10 treatments within 2 weeks) Measure immediately post VITM but post taVNS treatment
Primary	Visual VITM Self-Reported Likert Scale for Desire (1 for no sexual inducement effect to 5 for intense sexual inducement effect)	Visual stimuli (VITM Visual Inducer Testing Media Software) used to measure desire (sexual fantasy) intensity as opposed to phallometric medium	Day 1 Intervention applied (atVNS) immediately after VITM testing if subject tested positive for desire in T4 subgroup
Primary	Visual VITM Self-Reported Likert Scale for Desire (1 for no sexual inducement effect to 5 for intense sexual inducement effect))	Visual stimuli (VITM Visual Inducer Testing Media Software) used to measure desire (sexual fantasy) intensity as opposed to phallometric medium	Day 1 Intervention applied (atVNS) immediately after VITM testing if subject tested positive for desire in T5 subgroup
Primary	Visual VITM Self-Reported Likert Scale for Desire (1 for no sexual inducement effect to 5 for intense sexual inducement effect))	Visual stimuli (VITM Visual Inducer Testing Media Software) used to measure desire (sexual fantasy) intensity as opposed to phallometric medium	Day 10 Intervention applied (atVNS) daily for 10 days followed by the VITM self-reported Likert Scale for Desire - T4 Subgroup
Primary	Visual VITM Self-Reported Likert Scale for Desire (1 for no sexual inducement effect to 5 for intense sexual inducement effect))	Visual stimuli (VITM Visual Inducer Testing Media Software) used to measure desire (sexual fantasy) intensity as opposed to phallometric medium	Day 10 Intervention applied (atVNS) daily for 10 days followed by the VITM self-reported Likert Scale for Desire - T5 Subgroup

External Links

•   Academy North Canada Division for American University of Montserrat
•   Faculty of Medicine & University student information website